A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Implant survival at 2 years
Overview
Brief Summary
A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.
Detailed Description
Observational, multi-center, post-market study to provide data on the performance and safety of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
- •The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
- •Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
Exclusion Criteria
- •Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
- •Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Outcomes
Primary Outcomes
Implant survival at 2 years
Time Frame: 2 years
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
Secondary Outcomes
- Implant survival .(5 and 10 years)
- Radiographic assessment(2, 5, and 10 years)
- Relative change in Quality Of Life (EQ-5D) compared to baseline(2, 5, and 10 years)
- Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline(2, 5, and 10 years)
- Relative change of Range of Motion (ROM) compared to baseline(2, 5, and 10 years)
- Relative change in Quality Of Life (SF-12V1) compared to baseline(2, 5, and 10 years)
- Relative change of PENN Pain and Function Score (PENN) compared to baseline(2, 5, and 10 years)